- Upperton has submitted an application to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) seeking approval for its 7,000 sq. ft sterile manufacturing facility in Nottingham.
- The £7 million facility will support formulation development and clinical manufacturing of sterile drug products for early-phase biotech and pharmaceutical companies.
Upperton has submitted an application to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for approval of a 7,000 sq. ft sterile manufacturing facility in Nottingham, UK. The submission follows the completion of aseptic process simulation validation batches carried out under the revised EU GMP Annex 1 (2023) requirements.
The facility is designed to support formulation development and clinical manufacturing of aseptic and terminally sterilised drug products for parenteral, nasal, and pulmonary drug delivery. It will serve small and medium-sized biotech and pharmaceutical companies conducting pre-clinical through Phase 2 clinical studies. Initial manufacturing batch sizes will support up to 2,000 units.
The sterile manufacturing capability sits alongside Upperton’s existing 50,000 sq. ft development and manufacturing site in Nottingham. As a CDMO providing contract manufacturing and development services, the company offers formulation development, clinical manufacturing, and analytical testing across multiple dosage forms.
The facility was built in accordance with Eudralex Volume 4 Annex 1 requirements and incorporates contamination control strategies and specialised equipment, including Grade C cleanroom manufacturing suites, an Envair Technology solid wall VHP three-chamber isolator, a LAST Technology dry heat sterilizer depyrogenation oven, and an LTE Scientific autoclave for terminal sterilisation. Aseptic filling equipment from Flexicon, advanced HVAC systems, and pre-use post-sterilisation integrity testing (PUPSIT) have also been integrated.
“The team has worked tirelessly to achieve this outcome, particularly given the challenging landscape shaped by the updated Annex 1 guidelines. Everyone involved, across every department, has contributed to building an outstanding sterile manufacturing capability that meets the highest global standards.”
Nikki Whitfield, Chief Executive Officer at Upperton
The £7 million investment is intended to address limited small-scale aseptic manufacturing capacity in the CDMO sector, where delays of 12–18 months can occur for early-stage biopharma projects. The facility also includes a Grade C cleanroom intended for a future isolator to support aseptic spray-dried powder manufacturing, which the company expects to introduce in the fourth quarter of 2026.
